Contec Medical Systems Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example,

Passage 2

Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:

Passage 3

Failure to include a copy of all communications regarding the correction or removal in the report, as required by 21 CFR 806.10(c)(12). For example, you included a paragraph in the customer notification letter sent to consignees for an open recall (Z-1764-2025) that was omitted from the version of the letter sent to the FDA as part of the written report.